Athira says clinical trial of fosgonimeton for AD primary endpoint not met

Athira Pharma announced topline results from its Phase 2/3 LIFT-AD clinical trial of fosgonimeton, a hepatocyte growth factor HGF positive modulator, in patients with mild-to-moderate Alzheimer’s disease AD . The topline results showed that neither the trial’s primary endpoint the Global Statistical Test GST a combination of results from measures of cognition ADAS-Cog11 and function ADCS-ADL23 nor its key secondary endpoints of ADAS-Cog11 and ADCS-ADL23 reached statistical significance compared with placebo at 26 weeks. However, both components of GST, cognition and function directionally favored fosgonimeton treatment, and in pre-specified subgroups characterized by more rapid disease progression (moderate AD and APOE4 carriers , cognition and function improved or stabilized in the fosgonimeton treated group. In addition, data across biomarkers of protein pathology inflammation GFAP and neurodegeneration showed directional improvements with fosgonimeton treatment that are consistent with the broad neuroprotective mechanism of HGF modulation.”These are not the results we hoped for, as the lack of clinical decline in the placebo group, combined with the short duration of the study, may have impacted the trial’s ability to translate the effect of fosgonimeton treatment into meaningful clinical benefit,”said Javier San Martin, M.D., Chief Medical Officer of Athira. “However, we believe the totality of the data continues to suggest that positive modulation of the HGF pathway has the potential to translate into improvement in parameters of neuronal health and may mitigate disease progression.” “While the trial did not meet its primary endpoint, the biomarker and subgroup data are intriguing and remarkably consistent not only across endpoints but also with our understanding of fosgonimeton’s neuroprotective mechanism of action,” added Anton P. Porsteinsson, M.D ..”In addition to fosgonimeton, we have a pipeline of next-generation, orally delivered HGF modulators, with improved pharmacological properties, that we are currently evaluating in neurodegenerative diseases,” stated Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “We want to express our sincere appreciation for the patients, caregivers, their families, and healthcare professionals who participated in the LIFT-AD trial. I also want to thank all Athira employees for their dedication and tireless contributions to advancing the science to benefit patients battling neurodegenerative disease…